SoTalent ยท 8 hours ago
Senior Regulatory Affairs Specialist (Remote)
United States
Full-time
Remote
Senior Level, Lead/Staff
$150K/yr - $175K/yr
10+ years expSoTalent is a leading life sciences and regulatory consulting organization seeking a Senior Regulatory Affairs Specialist (CMC) to lead and execute global regulatory strategies for investigational, clinical, and marketed products. This role serves as a trusted regulatory advisor, partnering with clients to ensure compliance with global health authority requirements while supporting efficient product development and business outcomes.
Staffing & Recruiting
Responsibilities
Lead global CMC regulatory strategies supporting clinical development and lifecycle management
Author and compile CMC sections for regulatory submissions including INDs, IMPDs, CTAs, amendments, and annual reports
Prepare high-quality regulatory documentation (Modules 2 & 3, stability reports, comparability protocols)
Support and lead interactions with global health authorities (FDA, EMA, PMDA, and others)
Draft and coordinate responses to CMC-related regulatory questions
Contribute to the development of regulatory templates, processes, and workflows
Manage multiple deliverables and timelines in a fast-paced, client-facing environment
Qualification
Required
Bachelor's, Master's, or PhD in Biochemistry, Chemistry, Biology, or a related pharmaceutical discipline
10+ years of experience in CMC Regulatory Affairs
Hands-on experience authoring and compiling CMC sections for global regulatory submissions
Strong knowledge of FDA, EMA, ICH, and global CMC regulatory requirements
Excellent technical writing, organizational, and communication skills
Ability to manage complex projects across multiple stakeholders
Experience with regulatory document management systems
Company
SoTalent
At SoTechTalent, we specialise in connecting forward-thinking tech companies with world-class talent.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase